International Conference on Harmonisation (ICH)
Jason Rock, GlobalSubmit’s Chief Technology Officer, participates regularly in the ICH Multi-Disciplinary Group 2 (M2) Expert Working Group (EWG) as a representative of the FDA. Jason represents the FDA’s technical interests to ensure decisions reflect the best interest of the FDA and the health care industry as a whole.
Jason Rock serves as the project manager coordinating the activities of members involved in the XForms development project. This project involves the development of XForms for several HL7 messages. These XForms can be used to create electronic regulatory documents for HL7 messages to be submitted to the FDA. These HL7 messages include the following formats: Regulated Product Submission, Structured Product Labelling, Individual Case Safety Report, Stability Data and the Study Protocol (protocols, protocol summaries and study data). The Structured Product Labelling XForm is mentioned in FDA guidance.
Every year, GlobalSubmit presents a series of public educational webinars. Recent topics have included Intro to eCTD, eCTD Status and Regulations Worldwide, Introduction to Regulated Product Submissions (RPS), eCTD Archiving Options and Best Practices, eCTD File Formats: Regulations and Regional Differences, Best Practices in eCTD Submission Reviewing, eCTD File Formats: Regulations and Regional Differences, Scanned Document eCTD Readiness, eCTD Metadata, and eCTD operators - ending the confusion. If you are a sponsor who missed one of these webinars and would like to receive the associated presentation, please contact GlobalSubmit Marketing. Also, check our Events page for upcoming webinars. Our webinars are always free and open to the entire sponsor community.
GlobalSubmit authors the industry’s most widely read eSubmissions blog, The eCTD Summit. Our blog will keep you up to date on new regulations and guidance (analysed in detail), Agency news and presentations, and industry trends. For up-to-the-minute news, follow GlobalSubmit on Twitter at www.twitter.com/globalsubmit.
GlobalSubmit monitors eSubmissions-related pages on Wikipedia, and contributes by keeping them up to date and adding missing content.
GlobalSubmit’s thought leaders are sought-after speakers. We recently spoke at the DIA Annual Meeting, DIA Electronic Document Management conference, Exl Pharma, and OpeneCTD. Please contact Jason Rock if you would like a copy of one of our presentations or if you’re organizing a conference and looking for an insightful presentation.